In short
Clinical trials are investigating LTX-002 SODIUM in adults with amyotrophic lateral sclerosis (ALS). The studies are looking at safety, tolerability, and other effects after treatment given into the spinal canal. They compare LTX-002 SODIUM with placebo in a small participant group.
Key points
- LTX-002 SODIUM is being studied in clinical trials for adults with amyotrophic lateral sclerosis (ALS). The available trial is an early Phase 1/2 study, which means it is designed to look at safety and early effects. Participants receive LTX-002 SODIUM by intrathecal administration, meaning it is given into the spinal canal. The study compares LTX-002 SODIUM with placebo. Main measures include side effects, lab tests, ECGs, vital signs, and physical and neurological exams.
Trial overview
The available study for LTX-002 SODIUM is an interventional clinical trial in adults with amyotrophic lateral sclerosis (ALS). It is designed to evaluate the safety and effects of LTX-002 SODIUM when it is given in the spinal canal, and it compares the study treatment with placebo.
The study is in Phase 1/2, which means it is an early-stage trial that looks at safety and also at early signs of benefit. The source describes the study as authorised.
Who can participate
The trial is for adult participants with ALS. The source data does not list full entry rules such as age limits beyond adulthood, disease stage, or other health requirements.
This means the study team would need to check whether a person fits the study rules before enrollment.
How the study is run
LTX-002 SODIUM is given by intrathecal administration, which means it is delivered into the intrathecal space in the spinal canal. The spinal canal is the space in the spine that surrounds the spinal cord and contains spinal fluid.
The comparison treatment is placebo, which is made to look like the study medicine but does not contain an active substance. In this trial, the placebo is a corresponding volume of sterile aCSF solution formulation intended for intrathecal use.
What is being measured
The main goal is to check safety and tolerability, meaning how well participants can receive the study treatment without major problems.
The primary outcomes include the incidence and severity of adverse events, treatment-emergent adverse events, and serious adverse events. These are medical problems that happen during the study, including problems that start after treatment begins and problems that are severe enough to be considered serious.
The study also measures clinical laboratory tests, including serum chemistry, hematology, and urinalysis. These tests check blood and urine for signs of health changes during the trial.
Other measurements include ECGs, vital signs, and physical and neurological exams. ECGs record the heart’s electrical activity, vital signs include blood pressure, heart rate, breathing rate, and body temperature, and neurological exams check how the nervous system is working.
Study status and size
The study is listed as authorised and has an enrollment target of 56 participants. This is a relatively small trial, which is common in early research stages when safety is being studied first.
The trial is interventional, so participants are assigned to receive a study treatment or placebo as part of the research plan.
Patient glossary
- ALS: a disease that affects nerve cells and can lead to muscle weakness and loss of movement.
- Placebo: a look-alike treatment with no active substance, used for comparison.
- Intrathecal: given into the space around the spinal cord.
- Phase 1/2: an early study phase that focuses on safety and early signs of effect.
- Serum chemistry: blood tests that look at chemicals in the blood to help check organ function.
- Hematology: blood tests that check blood cells and related health information.
- Urinalysis: a urine test that can show signs of health changes.
- Neurological exam: a check of how the brain, nerves, and muscles are working.